STERILUCENT SELF-SEAL STERILIZATION POUCH— 510(k) K141412

Substantially Equivalent

Gs Medical Packaging, Inc.

FDA 510(k) clearance K141412 for STERILUCENT SELF-SEAL STERILIZATION POUCH, Substantially Equivalent on 2014-12-03. Applicant: Gs Medical Packaging, Inc..

Clearance details

Applicant: Gs Medical Packaging, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2014-05-29
Decision date: 2014-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.